TALKING TRACH
FDA 510(k) clearance K062104 · decided 2007-04-20
Clearance details
- K-number
- K062104
- Device name
- TALKING TRACH
- Applicant
- Engineered Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-24
- Decision date
- 2007-04-20
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.